Post-Marketing Safety of SARS-CoV-2 mRNA-1273 Vaccine in the US: Active Surveillance, Signal Refinement and Self-Controlled Risk Interval (SCRI) Signal Evaluation in HealthVerity (COVID-19)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  This study aims to augment ongoing active and passive safety signal detection through signal refinement and, where warranted, evaluation of potential safety signals associated with the introduction of SARS-CoV-2 mRNA-1273 vaccine.

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ELASOMERAN

  IMELASOMERAN
• Medical condition to be studied:
  Anaphylactic reaction

  Liver injury

  Acute disseminated encephalomyelitis

  Acute kidney injury

  Acute myocardial infarction

  Acute respiratory distress syndrome

  Anosmia

  Deep vein thrombosis

  Arthritis

  Arrhythmia
• Additional medical condition(s):
  Aseptic meningitis,Bell’s palsy,Chilblain-like lesions,Chronic coronary heart disease,Coagulation disorders,Deep vein thrombosis (DVT),Disseminated intravascular coagulation (DIC),Encephalitis / Encephalomyelitis,Erythema multiforme,Gestational diabetes,Guillain-Barré Syndrome (GBS),Heart failure,Kawasaki disease,Meningoencephalitis,Microangiopathy,Multisystem Inflammatory Syndrome in Adults

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1400000

Study design details

• Main study objective:
  The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.
• Outcomes:
  Number of Participants With Adverse Events of Special Interests (AESIs)
• Data analysis plan:
  Background and vaccine-exposed IRs in US adults will be stratified by age group, sex, and calendar period. when the pre-specified criteria are met for a particular AESI, the observed vs expected event ratios (O/Es) and corresponding 95% CI will be calculated, as the ratio of the number of events among those vaccinated with mRNA-1273 to the number of events expected in this population from background rates. when the pre-specified criteria are met for a particular AESI, the risk ratio (RR) of each AESI triggered in Objective 2 will be estimated using a self-controlled risk interval (SCRI) design and fitting a conditional regression model (Poisson or negative binomial) based on model dispersion. Each AESI will be assigned specific risk and control periods based on biologically plausible mechanisms. Sensitivity analyses may be performed by applying different risk and control periods.